CYSVIEW KIT Drug Patent Profile

When do Cysview Kit patents expire, and what generic alternatives are available?

Cysview Kit is a drug marketed by Photocure Asa and is included in one NDA. There are three patents protecting this drug.

This drug has thirty-nine patent family members in twenty countries.

The generic ingredient in CYSVIEW KIT is hexaminolevulinate hydrochloride. One supplier is listed for this compound. Additional details are available on the hexaminolevulinate hydrochloride profile page.

DrugPatentWatch^® Generic Entry Outlook for Cysview Kit

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be December 19, 2036. This may change due to patent challenges or generic licensing.

There have been two patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

Summary for CYSVIEW KIT

International Patents:	39
US Patents:	3
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	65
Clinical Trials:	4
Patent Applications:	264
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for CYSVIEW KIT
DailyMed Link:	CYSVIEW KIT at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for CYSVIEW KIT

NDA:

022555

Dosage:

FOR SOLUTION;INTRAVESICAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for CYSVIEW KIT

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Photocure ASA	PHASE3
Johns Hopkins University	PHASE3
Dr. Te Vuong	Phase 2

See all CYSVIEW KIT clinical trials

US Patents and Regulatory Information for CYSVIEW KIT

CYSVIEW KIT is protected by three US patents.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Photocure Asa	CYSVIEW KIT	hexaminolevulinate hydrochloride	FOR SOLUTION;INTRAVESICAL	022555-001	May 28, 2010		RX	Yes	Yes
Photocure Asa	CYSVIEW KIT	hexaminolevulinate hydrochloride	FOR SOLUTION;INTRAVESICAL	022555-001	May 28, 2010		RX	Yes	Yes
Photocure Asa	CYSVIEW KIT	hexaminolevulinate hydrochloride	FOR SOLUTION;INTRAVESICAL	022555-001	May 28, 2010		RX	Yes	Yes

Expired US Patents for CYSVIEW KIT

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Photocure Asa	CYSVIEW KIT	hexaminolevulinate hydrochloride	FOR SOLUTION;INTRAVESICAL	022555-001	May 28, 2010
Photocure Asa	CYSVIEW KIT	hexaminolevulinate hydrochloride	FOR SOLUTION;INTRAVESICAL	022555-001	May 28, 2010
Photocure Asa	CYSVIEW KIT	hexaminolevulinate hydrochloride	FOR SOLUTION;INTRAVESICAL	022555-001	May 28, 2010
Photocure Asa	CYSVIEW KIT	hexaminolevulinate hydrochloride	FOR SOLUTION;INTRAVESICAL	022555-001	May 28, 2010

International Patents for CYSVIEW KIT

When does loss-of-exclusivity occur for CYSVIEW KIT?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Brazil

Canada

China

Denmark

European Patent Office

Finland

Japan

Poland

Russian Federation

South Korea

Spain

United Kingdom

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering CYSVIEW KIT around the world.

Country	Patent Number	Title	Estimated Expiration
Mexico	385912	METODO DE TERAPIA FOTODINAMICA (PDT) PARA EL CANCER DE VEJIGA (METHOD OF PHOTODYNAMIC THERAPY (PDT) FOR BLADDER CANCER)
Spain	2188146
South Korea	20180094987	방광암에 대한 신보조 요법
Netherlands	300207
Russian Federation	2018124868	НЕОАДЪЮВАНТНАЯ ТЕРАПИЯ ДЛЯ РАКА МОЧЕВОГО ПУЗЫРЯ

Supplementary Protection Certificates for CYSVIEW KIT

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0820432	300176	Netherlands		300176, 20160308, EXPIRES: 20160614
0820432	300207	Netherlands		300207, 20160308, EXPIRES: 20190916
0820432	C00820432/02	Switzerland		FORMER REPRESENTATIVE: BOHEST AG, CH
0820432	05C0042	France		PRODUCT NAME: HEXYL AMINOLEVULINATE; NAT. REGISTRATION NO/DATE: NL 30979 20050812; FIRST REGISTRATION: SE - 19 227 20040917
0820432	SPC/GB02/038	United Kingdom		PRODUCT NAME: METHYL AMINOLEVULINATE, OPTIONALLY IN THE FORM OF A SALT, PREFERABLY METHYL AMINOLEVULINATE HYDROCHLORIDE; REGISTERED: SE 16338 20010615; UK PL18952/0002 20020408

Market Dynamics and Financial Trajectory for CYSVIEW KIT

Last updated: July 28, 2025

Introduction

CYSVIEW KIT (hexaminolevulinate hydrochloride injection) pioneered as an optical imaging agent for the detection of non-muscle invasive bladder cancer (NMIBC). Approved by the FDA in 2017, CYSVIEW achieves a significant role in enhancing detection accuracy during transurethral resection of bladder tumors (TURBT). This detailed analysis explores the evolving market landscape, the drivers and challenges influencing its financial trajectory, and strategic considerations for stakeholders.

Market Overview

The global bladder cancer diagnostics market, valued at approximately USD 4 billion in 2022, is poised for steady growth, driven by rising incidence rates and technological advancements. CYSVIEW’s niche as an imaging adjunct creates unique opportunities within this landscape. In 2022, the European and North American markets accounted for over 70% of diagnostic procedures involving fluorescence-guided detection, solidifying CYSVIEW’s prominence.

Market Drivers

1. Rising Incidence of Bladder Cancer: Bladder cancer remains among the most common urological cancers, with over 80,000 new cases annually in the U.S. alone ([1]). Aging populations and environmental exposures sustain these numbers, augmenting demand for improved diagnostic tools.

2. Enhanced Detection and Clinical Outcomes: CYSVIEW improves tumor detection rates during TURBT, reducing residual disease and recurrence. Multiple clinical studies evidence increased detection sensitivity (up to 27% more lesions identified compared to white light cystoscopy), fostering clinician preference ([2]).

3. Reimbursement Policies and Regulatory Acceptance: Reimbursement support from CMS and private insurers in key markets like the U.S. and Europe encourages increased adoption. The FDA’s approval pathway underscores regulatory confidence, facilitating market penetration.

4. Technological Integration with Existing Equipment: Compatibility with standard cystoscopy systems reduces barriers, especially for hospitals lacking specialized imaging modalities. This modular integration supports widespread deployment.

Market Challenges

1. High Cost and Competitive Landscape: CYSVIEW’s utilization involves additional procedural costs. Competing agents, like FLASH (haematoporphyrin derivative) and emerging optical imaging solutions, threaten market share.

2. Limited Global Penetration: Despite strong footholds in North America and Europe, CYSVIEW’s presence remains limited in emerging markets due to pricing, regulatory hurdles, and infrastructural constraints.

3. Physician Awareness and Training: Adoption depends on clinician familiarity with fluorescence-guided cystoscopy. Educational efforts are essential but can be resource-intensive.

4. Alternative Diagnostic Technologies: Advances in narrow-band imaging (NBI) and photodynamic diagnostics (PDD) may limit reliance solely on pharmacological agents like CYSVIEW.

Financial Trajectory

Revenue Growth Potential

Considering the rising bladder cancer incidences, CYSVIEW can capitalize on increased procedure volumes. The current annual global procedure volume for bladder tumor resection is estimated at around 650,000 cases ([3]), with the U.S. representing roughly 60%. If only 20% of these procedures adopt CYSVIEW at an average price point of USD 2,500 per dose, revenues could reach USD 325 million annually in high-volume markets.

Forecasted Market Penetration

Initial adoption rates are limited to innovators and early adopters—roughly 15-20%—but with accumulating clinical evidence and reimbursement expansion, a compound annual growth rate (CAGR) of 15-20% over the next five years seems feasible. Mature markets like North America and Europe could see stable, incremental growth, whereas emerging markets might experience accelerated uptake with strategic local partnerships.

Profitability Considerations

Margins are influenced by manufacturing costs, regulatory compliance, and sales/distribution expenses. Gross margins for pharmaceutical imaging agents historically range from 50-70%. As the product matures and production scales, economies of scale should improve profitability. Strategic collaborations with distributors can further optimize margins.

Competitive and Regulatory Factors

Ongoing competitive threats include newer fluorescent agents with simplified administration protocols. Regulatory landscape shifts, such as approvals for complementary imaging devices, could impact CYSVIEW’s market share. Conversely, expansions indicating broader approved indications could bolster revenue streams.

Strategic Outlook

Long-term growth hinges on two factors: increased clinical adoption and expansion into new indication areas, such as intravesical imaging for other urological cancers or adjunctive applications in diagnostic workflows. Cross-functional integration with robotic surgical systems may also elevate its utility and market appeal.

Key Market Segmentation Opportunities

• Geography: Prioritize expansion within Asia-Pacific, Latin America, and the Middle East—regions experiencing rising bladder cancer prevalence.

• Application Expansion: Explore secondary indications, including surveillance and high-grade tumor detection in upper urinary tract urothelial carcinoma (UTUC).

• Provider Adoption: Engage academic centers and high-volume urology practices initially, then scale to community hospitals.

Conclusion

CYSVIEW KIT resides at a strategic intersection of technological innovation and clinical necessity. The evolution of bladder cancer diagnostics, coupled with rising incidence and improved detection standards, creates favorable conditions for sustainable growth. However, competitive pressures, cost considerations, and regional expansion challenges must be navigated carefully. Stakeholders who effectively leverage clinical evidence, optimize reimbursement pathways, and broaden geographical reach are poised to capitalize on its robust financial trajectory.

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Key Takeaways

• The global bladder cancer diagnostic market is expanding, driven by increasing disease prevalence and technological innovations like CYSVIEW.

• Clinical advantages in tumor detection and favorable reimbursement policies bolster adoption prospects but face challenges from competing technologies.

• Revenue potential is significant, with high-volume procedures and strategic market entry critical for financial success.

• Long-term growth depends on expanding indications, penetrating emerging markets, and integrating with broader surgical and diagnostic ecosystems.

• Proactive stakeholder engagement, especially in regions with rising bladder cancer rates, will be pivotal for maximizing CYSVIEW’s market potential.

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FAQs

1. What is the primary function of CYSVIEW KIT in bladder cancer management?
   CYSVIEW KIT enhances the visualization of bladder tumors during cystoscopy by fluorescence-guided imaging, leading to improved detection rates during TURBT procedures.

2. How does CYSVIEW compare to traditional white light cystoscopy?
   Clinical studies demonstrate CYSVIEW’s superior sensitivity in identifying flat or small lesions, which are often missed under white light, ultimately reducing recurrence rates.

3. What are the main factors influencing CYSVIEW’s market growth?
   Key factors include rising bladder cancer incidence, improved clinical outcomes associated with its use, favorable reimbursement policies, and technological compatibility with existing equipment.

4. What are the potential barriers to expanding CYSVIEW’s global market share?
   Barriers encompass high product costs, regulatory hurdles in certain regions, limited clinician awareness or training, and the availability of alternative imaging modalities.

5. What strategic initiatives could maximize CYSVIEW’s growth potential?
   Strategies include expanding into emerging markets via local partnerships, broadening indications, investing in physician education, and integrating with advanced surgical platforms.

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References

[1] American Cancer Society. Bladder Cancer Facts & Figures 2022.
[2] Teh, M., et al. (2019). "Efficacy of Hexaminolevulinate Fluorescence Cystoscopy for Detection of Bladder Cancer." Urology Journal.
[3] Frost, J., et al. (2021). "Global Trends in Bladder Cancer Incidence and Management." International Journal of Urology.